Ensuring Patient Safety in Clinical Trials FP7 Project: Linked2Safety

Dr. Ratnesh Sahay, Dr. Ronan Fox

DERI, NUIGGalway, Ierland

Convergence Meeting: Semantic Interoperability for Clinical Research & Patient Safety in Europe

Convergence Meeting: Semantic Interoperability for Clinical Research &

Patient Safety in Europe1/15

Partners

Convergence Meeting: Semantic Interoperability for Clinical Research &

Patient Safety in Europe

1. INTRASOFT INTERNATIONAL SA, Belgium2. UNIVERSITY OF CYPRUS, Cyprus 3. DERI-NATIONAL UNIVERSITY OF IRELAND, GALWAY, Ireland4. UNIVERSITY OF MANCHESTER, UK 5. CENTRE FOR RESEARCH AND TECHNOLOGY HELLAS (CERTH), Greece6. SIVECO Romania S.A 7. UBITECH Research, Greece8. GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER (LUH), Germany9. Cyprus Institute of Neurology and Genetics (CING), Greece10. ZEINCRO Hellas S.A., Greece11. HOSPICES CANTONAUX CHUV, Switzerland

2/15

The Problem

return number of subjects (i.e., patients) that have been administered the drug

Insulin and exhibit BMI > 25 and Dyslipidemia and Agoraphobia as adverse events

RxNorm LOINC SNOMED DSM-4

Legal and Ethical Regulations

HL7/openEHR

3/15Convergence Meeting: Semantic

Interoperability for Clinical Research & Patient Safety in Europe

Showcases

Convergence Meeting: Semantic Interoperability for Clinical Research &

Patient Safety in Europe

Phase III Clinical Trial – Subject Selection Criteria the unbiased randomised selection of subjects in phase III

clinical trials e.g. return subjects with diabetesValue > 4 and weight >80 and

hasCancer Phase IV – Post Marketing Surveillance

the pharmacovigilance of a drug after it receives permission to be sold

e.g. Test DrugX association with headaches Phase IV – Chemoinformatics

identification of relations between molecular fragments and specific adverse drug event categories

e.g. Test chemicalFragmentX (of DrugX) with rash

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Objectives Enable Patient Safety in clinical trials

anonymisation of clinical site anonymisation of clinical data

Build a semantically-interlinked medical information space recruit patients across European clinical data sets adverse event detection

Support effective organization and execution of clinical trials embedding governance / legal / ethics in process

Convergence Meeting: Semantic Interoperability for Clinical Research &

Patient Safety in Europe

5/15

Safety First – Ethical & Legal Aspects

Convergence Meeting: Semantic Interoperability for Clinical Research &

Patient Safety in Europe

Respect patients’ anonymity, data’s ownership and privacy Not possible to transfer or copy patient data from the

originating institutions All machines that hold patient data are need to remain off-

line Clinical data will not be identifiable and should not lead to

the identification of a person’s identity (either directly or indirectly e.g. back-tracing)

Strictly adhere to consent form requirements and all ethical and legal issues (European and national)

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Data Anonymisation Addresses legal and ethical issues by

Closed-world room pre-processingUsage of data-cubes

Convergence Meeting: Semantic Interoperability for Clinical Research &

Patient Safety in Europe7/15

Is data anonymised enough ?

16 year old widow Problem

8/15Convergence Meeting: Semantic

Interoperability for Clinical Research & Patient Safety in Europe

16 year old widow Problem

Is data anonymised enough ?

9/15Convergence Meeting: Semantic

Interoperability for Clinical Research & Patient Safety in Europe

Perturbation and Cell Suppression

Original Data Perturbation (+-1) andCell Suppression (<5)

10/15Convergence Meeting: Semantic

Interoperability for Clinical Research & Patient Safety in Europe

Linked2Safety – Approach

Linked Data Cubes

Semantic EHR ModelPolicy Model

11/15Convergence Meeting: Semantic

Interoperability for Clinical Research & Patient Safety in Europe

Semantic EHR Model

ACGT

BFO

imports

imports

Do

ma

in

SEHR

CHUVCardiovascularPsychiatricAdverse Events

CINGBreast CancerDiabeticNeurologyGeneticsAdverse Event (AE)

ZEINCROAdverse Event (AE) Concomitant Medication (CE)Respiratory

UP

PE

R

UMLS, OBO Foundry(Basic Formal Ontology)

Advancing Clinico-Genomic Trials on Cancer (ACGT)

Class 1859

Object Property 225

Data Property 575

12/15Convergence Meeting: Semantic

Interoperability for Clinical Research & Patient Safety in Europe

Policy-Based User Restricted Resources

R1 R3P1

R4

P3

R2

P2

R5

P4

Data Cube

+

R1 #P4

Query

R1 R5P4

Result

R1 R3

R5

P4

View

P1

R1 #P1

# #P4

Access P

olicy

13/15Convergence Meeting: Semantic

Interoperability for Clinical Research & Patient Safety in Europe

Current Status

Basic prototypes completedData-cube building at clinical sitesSpecial Interest Group (SIG) recruitmentLegal ethical framework and exploitation strategy

14/15Convergence Meeting: Semantic

Interoperability for Clinical Research & Patient Safety in Europe

ContactDr. Ratnesh Sahay, Dr. Ronan Fox

DERI, NUIGTel: +353 91 495253Fax: +353 91 495541

email: firstname.lastname@deri.org

http://www.linked2safety-project.eu/user/register Join SIG @

Thank You

15/15Convergence Meeting: Semantic

Interoperability for Clinical Research & Patient Safety in Europe